Baseer Maroof, LCSW · Raleigh, NC · Adults 21+
Meds & supplements
Pills can help short-term. They aren’t first-line, and the effect usually ends when they do.
In short
- Guidelines put CBT-I first. Medication is an option when it isn’t enough or isn’t available, decided together with a prescriber.
- The AASM’s medication recommendations are all weak. The evidence for any single drug is modest.
- CBT-I holds up after treatment ends; medication effects generally don’t outlast the pills.
- Over-the-counter options (antihistamines, melatonin, valerian) aren’t recommended for chronic insomnia by the AASM.
CBT-I vs medication
Short vs long run
A review of head-to-head studies found medication may help a bit faster at first, while CBT-I did better over the long term (very low-grade evidence, 5 studies). (Mitchell 2012)
Using both
In a trial of 160 adults, 6 weeks of CBT alone or CBT plus zolpidem worked about equally (response 60% vs 61%). The best long-term result came from starting combined and then stopping the medication while continuing CBT: 68% remission at 6 months, vs 42% when zolpidem was continued. (Morin 2009)
What guidelines say
ACP: CBT-I first; medication by shared decision if CBT-I alone fails, ideally for a short period (their release says 4–5 weeks). European 2023: most hypnotics short-term only (up to 4 weeks); orexin antagonists can be used up to 3 months or longer. (ACP 2016; ACP press release; Riemann 2023)
Prescription options
Talk to your doctor before starting, stopping or combining any of these.
AASM 2017: suggested (weak) for
Orexin antagonist suvorexant; “Z-drugs” eszopiclone, zaleplon, zolpidem; benzodiazepines triazolam, temazepam; ramelteon; low-dose doxepin. Which one depends on whether the problem is falling or staying asleep. (Sateia 2017)
AASM 2017: suggested against
Trazodone, tiagabine, diphenhydramine, melatonin, tryptophan and valerian, for chronic insomnia. (Sateia 2017)
Z-drug safety
In 2019 the FDA added a boxed warning to eszopiclone, zaleplon and zolpidem for complex sleep behaviors such as sleepwalking and sleep driving, which have caused serious injuries and deaths. (FDA 2019)
Orexin antagonists
They block a wake-promoting signal rather than sedating broadly. FDA approvals: suvorexant (2014), lemborexant (2019), daridorexant (2022). (Merck; Eisai; FDA)
Over-the-counter & supplements
Antihistamines
Diphenhydramine is the AASM’s “suggest against” for chronic insomnia, and the European guideline doesn’t recommend antihistamines. (Sateia 2017; Riemann 2023)
Melatonin
Not recommended by the AASM for chronic insomnia. The European guideline allows prolonged-release melatonin for up to 3 months in people 55 and older. Quality is a real problem: in 31 supplements, content ranged from 83% less to 478% more than the label, and 8 contained serotonin. Of 25 US gummy products, 22 were mislabeled, at 74–347% of the stated dose. (Sateia 2017; Riemann 2023; Erland 2017; Cohen 2023)
Herbal
Valerian: AASM suggests against. The European guideline doesn’t recommend phytotherapeutics. (Sateia 2017; Riemann 2023)
Sources
All sources, linked12 references⌄
- Qaseem A, et al. (2016). Management of chronic insomnia disorder in adults: a clinical practice guideline from the American College of Physicians. Ann Intern Med 165(2):125–133. www.acpjournals.org/doi/10.7326/M15-2175
- American College of Physicians (May 2016). ACP recommends cognitive behavioral therapy as initial treatment for chronic insomnia (press release). www.acponline.org/acp-newsroom/acp-recommends-cognitive-behavioral-therapy-as-initial-treatment-for-chronic-insomnia
- Riemann D, et al. (2023). The European Insomnia Guideline: an update on the diagnosis and treatment of insomnia 2023. J Sleep Res 32(6):e14035. doi.org/10.1111/jsr.14035
- Sateia MJ, et al. (2017). Clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults: an AASM clinical practice guideline. J Clin Sleep Med 13(2):307–349. pmc.ncbi.nlm.nih.gov/articles/PMC5263087/
- U.S. FDA (April 30, 2019). FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines (eszopiclone, zaleplon, zolpidem). www.fda.gov/safety/medical-product-safety-information/certain-prescription-insomnia-medicines-new-boxed-warning-due-risk-serious-injuries-caused
- Merck (August 13, 2014). FDA approves BELSOMRA (suvorexant) for the treatment of insomnia. www.merck.com/news/fda-approves-belsomra-suvorexant-for-the-treatment-of-insomnia/
- Eisai (December 23, 2019). U.S. FDA approves Eisai’s DAYVIGO (lemborexant) for the treatment of insomnia in adult patients. media-us.eisai.com/2019-12-23-U-S-FDA-Approves-Eisais-DAYVIGO-TM-lemborexant-for-the-Treatment-of-Insomnia-in-Adult-Patients
- U.S. FDA. Drug Trials Snapshots: QUVIVIQ (daridorexant), approved January 7, 2022. www.fda.gov/drugs/drug-trials-snapshots/drug-trials-snapshots-quviviq
- Mitchell MD, et al. (2012). Comparative effectiveness of cognitive behavioral therapy for insomnia: a systematic review. BMC Fam Pract 13:40. pubmed.ncbi.nlm.nih.gov/22631616/
- Morin CM, et al. (2009). Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: a randomized controlled trial. JAMA 301(19):2005–2015. pubmed.ncbi.nlm.nih.gov/19454639/
- Erland LAE, Saxena PK (2017). Melatonin natural health products and supplements: presence of serotonin and significant variability of melatonin content. J Clin Sleep Med 13(2):275–281. pubmed.ncbi.nlm.nih.gov/27855744/
- Cohen PA, Avula B, Wang Y-H, Katragunta K, Khan I (2023). Quantity of melatonin and CBD in melatonin gummies sold in the US. JAMA 329(16):1401–1402. doi.org/10.1001/jama.2023.2296
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